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Randomised controlled trial of a person-centred transition programme for adolescents with type 1 diabetes (STEPSTONES-DIAB): a study protocol.

ABSTRACT: INTRODUCTION:Adolescence is a critical period for youths with chronic conditions, when they are supposed to take over the responsibility for their health. Type 1 diabetes (T1D) is one of the most common chronic conditions in childhood and inadequate self-management increases the risk of short-term and long-term complications. There is a lack of evidence regarding the effectiveness of transition programmes. As a part of the Swedish Transition Effects Project Supporting Teenagers with chrONic mEdical conditionS research programme, the objective of this study is to evaluate the effectiveness and experiences of different transitional care models, including a person-centred transition programme aiming to empower adolescents with T1D to become active partners in their health and care. METHODS AND ANALYSIS:In this randomised controlled trial, patients are recruited from two paediatric diabetes clinics at the age of 16 years. Patients are randomly assigned to either the intervention group (n=70) where they will receive usual care plus the structured transition programme, or to the control group (n=70) where they will only receive usual care. Data will be collected at 16, 17 and 18.5 years of age. In a later stage, the intervention group will be compared with adolescents in a dedicated youth clinic in a third setting. The primary outcome is patient empowerment. Secondary outcomes include generic, diabetes-specific and transfer-specific variables. ETHICS AND DISSEMINATION:The study has been approved by the Ethical Review Board in Stockholm (Dnr 2018/1725-31). Findings will be reported following the Consolidated Standards of Reporting Trials statement and disseminated in peer-reviewed journals and at international conferences. TRIAL REGISTRATION NUMBER:NCT03994536.

SUBMITTER: Brorsson AL

PROVIDER: S-EPMC7200039 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Randomised controlled trial of a person-centred transition programme for adolescents with type 1 diabetes (STEPSTONES-DIAB): a study protocol.

Brorsson Anna Lena AL Bratt Ewa-Lena EL Moons Philip P Ek Anna A Jelleryd Elisabeth E Torbjörnsdotter Torun T Sparud-Lundin Carina C

BMJ open 20200414 4

<h4>Introduction</h4>Adolescence is a critical period for youths with chronic conditions, when they are supposed to take over the responsibility for their health. Type 1 diabetes (T1D) is one of the most common chronic conditions in childhood and inadequate self-management increases the risk of short-term and long-term complications. There is a lack of evidence regarding the effectiveness of transition programmes. As a part of the Swedish Transition Effects Project Supporting Teenagers with chrO ...[more]

PMID: 32295780

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Project description:IntroductionToday, the majority of young persons living with chronic conditions in high-income countries survive into adulthood and will need life-long medical follow-up. Therefore, transition programmes have been developed to facilitate transfer to adult care, and to support self-management and independence during adulthood. The Swedish Transition Effects Project Supporting Teenagers with chrONic mEdical conditionS (STEPSTONES) project aims to evaluate the effectiveness of a person-centred transition programme for empowering adolescents with congenital heart disease in transition to adulthood. To understand how the transition programme causes change and how outcomes are created, process evaluation is imperative to assess implementation, context and mechanisms of impact. This protocol aims to describe the process evaluation of the STEPSTONES transition programme.Methods and designMedical Research Council guidance for process evaluation of complex interventions will be the guiding framework for this mixed-method study. The combination of qualitative and quantitative data will capture different aspects of programme delivery. The sample will consist of participants in the STEPSTONES randomised controlled trial (RCT), persons implementing the programme and healthcare professionals. Quantitative data will consist of protocols and routine monitoring documents from the RCT, data collected from patient registries and sociodemographic data to assess the implementation of the intervention. This data will be analysed with quantitative content analysis, along with descriptive and inferential statistics. Qualitative data will consist of participatory observations, logbooks and interviews with persons implementing the programme, participants and healthcare professionals. Analyses will be performed using qualitative content analysis to investigate mechanism of impact, context and delivery. Quantitative and qualitative data will be integrated in the final stage by using a triangulation protocol according to mixed-method guidelines.Ethics and disseminationThe study is approved by the Regional Ethical Review Board in Gothenburg, Sweden. Results will be presented in open access, peer-reviewed journals and at international scientific conferences.

Project description:IntroductionKnowledge is missing on use of information and communication technology (ICT), for example, mobile phones/tablets in rehabilitation after stroke. F@ce 2.0 is a person-centred, interdisciplinary intervention supported by ICT. The components of F@ce 2.0 intend to increase performance in daily activities and participation in everyday life for patients with stroke and their significant others. Based on previous feasibility studies, a full-scale evaluation is planned in Sweden. The aim is to implement and evaluate F@ce 2.0, regarding performance of daily activities and participation in everyday life, in comparison with ordinary rehabilitation among persons who have had stroke and significant others. Second, to increase knowledge about how the programme leads to a potential change by studying the implementation process and mechanisms of impact.Methods and analysisTwelve rehabilitation teams (intervention n=7; control n=5) will recruit patients (n=160) who receive rehabilitation at home after stroke and their significant others. F@ce 2.0 is an 8-week intervention where patients, together with the team, formulate three activity goals regarding what they need and want to do in daily lives. The patients will receive short messages service (SMS) each morning reminding about goals, and in the evening to rate their performance during the day. Primary outcomes for patients: self-efficacy measured by the Self-Efficacy Scale; perceived performance in daily activities measured by the Canadian Occupational Performance Measure. Significant others: perceived caregiver burden measured by Caregiver Burden Scale. Qualitative interviews with team members delivering, patients receiving intervention and significant others will explore experiences of F@ce 2.0. A process evaluation applying a case-study design using mixed methods will be conducted.Ethics and disseminationApproved by the Swedish Ethical Review Authority, Stockholm. Knowledge will be created for using ICT for rehabilitation of people after stroke in self-selected activities. Dissemination will include peer-reviewed publications, presentations at conferences, and information to stakeholders.Trial registration number detailsNCT04351178 .

Project description:BackgroundCare transitions following stroke should be bridged with collaboration between hospital staff and home rehabilitation teams since well-coordinated transitions can reduce death and disability following a stroke. However, health services are delivered within organisational structures, rather than being based on patients' needs. The aim of this study protocol is to assess the feasibility, operationalised here as fidelity and acceptability, of a codesigned care transition support for people with stroke.MethodsThis study protocol describes the evaluation of a feasibility study using a non-randomised controlled design. The codesigned care transition support includes patient information using videos, leaflets and teach back; what-matters-to me dialogue; a coordinated rehabilitation plan; bridged e-meeting; and a message system for cross-organisational collaboration. Patients with stroke, first time or recurrent, who are to be discharged home from hospital and referred to a rehabilitation team in primary healthcare for continued rehabilitation in the home will be included. One week after stroke, data will be collected on the primary outcome, namely satisfaction with the care transition support, and on the secondary outcome, namely health literacy and medication adherence. Data on use of healthcare will be obtained from a register of healthcare contacts. The outcomes of patients and significant others will be compared with matched controls from other geriatric stroke and acute stroke units, and with matched historic controls from a previous dataset at the intervention and control units. Data on acceptability and fidelity will be assessed through interviews and observations at the intervention units.Ethics and disseminationEthical approvals have been obtained from the Swedish Ethical Review Authority. The results will be published open-access in peer-reviewed journals. Dissemination also includes presentation at national and international conferences.DiscussionThe care transition support addresses a poorly functioning part of care trajectories in current healthcare. The development of this codesigned care transition support has involved people with stroke, significant other, and healthcare professionals. Such involvement has the potential to better identify and reconceptualise problems, and incorporate user experiences.Trial registration numberhttp://www.clinicaltrials.gov id: NCT02925871. Date of registration 6 October 2016.Protocol version1.

Project description:BackgroundThere is an increasing trend towards person-centred care (PCC) worldwide, suggesting that PCC should be mastered by future health care professionals. This study aims to explore programme directors' views on facilitators and barriers to implementing PCC in four of the largest national study programmes in Sweden training future health care professionals.MethodsA qualitative design was applied and interviews were conducted with 19 programme directors of Swedish national study programmes in medicine, nursing, occupational therapy and physiotherapy. The interviews were analysed using qualitative content analysis. Themes were sorted according to the Consolidated Framework for Implementation Research (CFIR) in an abductive approach. COREQ guidelines were applied.ResultsThe overarching theme, as interpreted from the programme directors' experiences, was 'Person-centred care is on the move at different paces.' The theme relates to the domains identified by the CFIR as outer setting, innovation, inner setting and process. PCC was understood as something familiar but yet new, and the higher education institutions were in a state of understanding and adapting PCC to their own contexts. The movement in the outer setting consists of numerous stakeholders advocating for increased patient influence, which has stirred a movement in the inner setting where the higher educational institutions are trying to accommodate these new demands. Different meanings and values are ascribed to PCC, and the concept is thus also 'on the move', being adapted to traditions at each educational setting.ConclusionImplementation of PCC in Swedish higher education is ongoing but fragmented and driven by individuals with a specific interest. There is uncertainty and ambiguity around the meaning and value of PCC and how to implement it. More knowledge is needed about the core of PCC as a subject for teaching and learning and also didactic strategies suitable to support students in becoming person-centred practitioners.

Project description:BackgroundThe majority of nursing home residents with dementia experience behavioural and psychological symptoms like apathy, agitation, and anxiety. According to analyses of prescription prevalence in Germany, antipsychotic drugs are regularly prescribed as first-line treatment of neuropsychiatric symptoms in persons with dementia, although guidelines clearly prioritise non-pharmacological interventions. Frequently, antipsychotic drugs are prescribed for inappropriate reasons and for too long without regular reviewing. The use of antipsychotics is associated with adverse events like increased risk of falling, stroke, and mortality. The aim of the study is to investigate whether a person-centred care approach, successfully evaluated in nursing homes in the United Kingdom, can be implemented in German nursing homes and, in comparison with a control group, can result in a clinically relevant reduction of the proportion of residents with antipsychotic prescriptions.Methods/designThe study is a cluster-randomised controlled trial comparing an intervention group (two-day initial training on person-centred care and ongoing training and support programme) with a control group. Both study groups will receive, as optimised usual care, a medication review by an experienced psychiatrist/geriatrician providing feedback to the prescribing physician. Overall, 36 nursing homes in East, North, and West Germany will be randomised. The primary outcome is the proportion of residents receiving at least one antipsychotic prescription (long-term medication) after 12 months of follow-up. Secondary outcomes are residents' quality of life, agitated behaviour, as well as safety parameters like falls and fall-related medical attention. A health economic evaluation and a process evaluation will be performed alongside the study.DiscussionTo improve care, a reduction of the current high prescription rate of antipsychotics in nursing homes by the intervention programme is expected.Trial registrationClinicalTrials.gov: NCT02295462.

Project description:BackgroundFibromyalgia (FM) is a contested, chronic widespread pain syndrome on which recommended therapies have short-lasting, moderate effects. Nevertheless, some patients become symptom-free, and their recovery experiences inspired us to develop a patient-centred recovery-oriented programme (PROP) delivered in a group format. Presently, we describe the theoretical rationale, purpose and content of the PROP, and its meanings for clinicians and patients.MethodsA multidisciplinary clinical team, a leader of a rehabilitation unit, and two researchers coproduced the PROP. Five full-day seminars were arranged to bridge research and clinical experiences. Qualitative studies about patients' illness and recovery experiences and questions by researchers facilitated reflections on clinical experiences. The meaning of the PROP was examined using focus group and individual interviews with patients and clinicians immediately after completing the course and after 1-1.5 years.ResultsThe biopsychosocial model displays the research evidence across biological, mental and social impacts of FM, justifying that life stress can be an illness-maintaining factor in FM. The content addresses enabling patients to heal their own life and self by modifying life stress. Patients engage in making sense of the relationship between FM, themselves, and life through exploring, discovering and creating appropriate solutions for their daily social life. The PROP reduced uncertainties and brought a positive attitude and hope to the groups. After 1 year, patients are still engaged in recovery work, experience more good days, and maintain hope for further recovery. By sharing and reflecting on clinical experiences, a unified clinical team was established that continues to develop their competency.ConclusionTo our knowledge, the PROP is the first programme for patients with FM that results from a process of coproducing knowledge, is based on explicit theoretical rationale, and facilitates a personal experiential recovery process. PROP is found to be meaningful and to work by patients and clinicians.

Dataset Information

Randomised controlled trial of a person-centred transition programme for adolescents with type 1 diabetes (STEPSTONES-DIAB): a study protocol.

Publications

Randomised controlled trial of a person-centred transition programme for adolescents with type 1 diabetes (STEPSTONES-DIAB): a study protocol.

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